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IRCT20130427013136N7 IRCT 2020-03-11 Babol University of Medical Sciences The effects of ciprofloxacin on the treatment of bacterial otitis media Comparison of therapeutic effect of ciprofloxacin powder and drops in the chronic bacterial otitis media 2018-09-23 anticipated 80 Complete https://irct.ir/trial/31411 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Ciprofloxacin powder is not available in Iran's drug store, thus the tablet form of this drug is converted into powder by a pharmacologist, Randomization description: According to inclusion and exclusion criteria, patients who referred to the physician will fall into two groups, consecutively. So that the first eligible patients will be entered in group 1 and the next one in group 2. Sampling will be continued till the desired number, Blinding description: In this study, the primary specialist is informed about the type of drug, due to the apparent difference between the packaging and its application of them, but another otolaryngologist will be evaluate the patients at the follow-up stage.Therefore, the judgment about the effectiveness of these drugs will be based only on the clinical findings of the disease at this stage, by the second specialist. Laboratory experts who make the final diagnosis according to direct examination and culture on media results, also will perform the necessary tests according to a patient code; and they are not aware of the patient group. All patients also aware of the type of treatment, depending on the form and how the drug is used. 3 Chronic bacterial otitis media. Intervention 1: Intervention group: After suction, 30 mg ciprofloxacin powder (Ronak pharmaceutical company, Kaveh industrial town, Iran) will use for once, by insufflation in to middle ear space and the existing perforation accompanying the microscopic guide. Intervention 2: Control group: After suctioning of the ear canal, 3 drops of ciprofloxacin 0.3% (Sina Darou Pharmaceutical Company, Tehran, Iran) are poured once into the ear canal. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Saeid Mahdavi Omran
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9936 s.mahdavi@mubabol.ac.ir Babol University of Medical Sciences scientific سعید مهدوی عمران
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9936 kia_ko13358@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients with chronic bacterial otitis media no limit no limit Both Suspected Patients to mixed bacterial and fungal otitis Suspected Patients to otomycosis patients with external otitis patients without rupture of the eardrum H65.3 Chronic mucoid otitis media Treatment - Drugs Treatment - Drugs Intervention group: After suction, 30 mg ciprofloxacin powder (Ronak pharmaceutical company, Kaveh industrial town, Iran) will use for once, by insufflation in to middle ear space and the existing perforation accompanying the microscopic guide. Control group: After suctioning of the ear canal, 3 drops of ciprofloxacin 0.3% (Sina Darou Pharmaceutical Company, Tehran, Iran) are poured once into the ear canal. Pain. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Severity of pain will determined by the patient's expression or pain index (Visual Analog Scale-VAS) which are between 0-10. Swelling. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Severity of swelling will determine based on the examination of the ear by the physician. Discharge. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Severity of discharge will determine based on the examination of the ear by the physician. Babol University of Medical Sciences Approved 2018-02-26 Ethics committee of Babol University of Medical Sciences School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street Babol Mazandaran Iran (Islamic Republic of)